FDA to Review sBLA for Jemperli for Earlier Treatment of Endometrial Cancer

The FDA has accepted GSK’s supplemental biologics license application (sBLA) for Jemperli (dostarlimab). The application seeks approval of Jemperli in combination with chemotherapy for the treatment of adult patients with primary advanced or recurrent endometrial cancer. It would be indicated for patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H). If approved, this would be the first frontline treatment advancement in decades for patients with primary advanced or recurrent endometrial cancer.

The FDA granted priority review for this application and assigned a Prescription Drug User Fee Act action date of Sept. 23, 2023.

“Long-term outcomes for patients with primary advanced or recurrent endometrial cancer remain poor, and there is an urgent need to evolve the current standard of care, which is platinum-based chemotherapy,” Hesham Abdullah, senior vice president, global head of oncology development at GSK, said in a press release.

Related: FDA Grants Full Approval to Jemperli for Endometrial Cancer

In February, Jemperli was granted full approved as monotherapy in dMMR recurrent or advanced endometrial cancer that has progressed on or following a prior platinum-containing regimen. The price of Jemperli is about $11,540 per 500 mg/10 mL vial, which is initially given once every three weeks for four doses, according to Drugs.com. GSK offers co-pay assistance of up of $26,000 for patients with commercial insurance.

Endometrial cancer is the most common gynecologic cancer globally, with about 417,000 new cases reported each year worldwide. About 15% to 20% of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis.

The supplemental application is based on the interim analysis results from Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase 3 trial. The trial met its primary endpoint of investigator-assessed progression-free survival (PFS). Results were published in the New England Journal of Medicine in March 2023. At a median follow-up of 24.8 months, the addition of Jemperli to carboplatin and paclitaxel reduced the risk of disease progression or death by 72%. The overall survival rate with Jemperli was 83.3% at 24 months.

Jemperli has also been granted accelerated approval for patients with dMMR recurrent or advanced solid tumors that have progressed on or following prior treatment.